Kitsaras George, Allan Julia, Pretty Iain A
1Dental Health Unit, Division of Dentistry, The University of Manchester, Manchester, UK.
2Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
Pilot Feasibility Stud. 2020 Feb 6;6:14. doi: 10.1186/s40814-020-0562-y. eCollection 2020.
This work concerns the activities in the last hour before bed for young children born to first-time parents, so called bedtime routines (BTR). These activities include amongst others tooth brushing, reading a book, having a bath and avoiding food and drinks before bed. Having a set bedtime at a suitable hour is also very important. Establishing good bedtime routines has been shown to be really important for a number of health, wellbeing, development and social outcomes. Currently, there is no evidence-based bedtime routine intervention for first-time parents using a novel design (i.e. text messages). Existing research has highlighted the importance of bedtime routines and the lack of appropriate mechanisms in place for parents who sought support.
The proposed study includes 2 work packages. Work package 1 focuses on the development of the intervention through a combination of qualitative work (1:1 interviews with parents on barriers and facilitators on bedtime routines using the Theoretical Domains Framework) and an expert group of key stakeholders. Work package 2 involves a small-scale ( = 50) feasibility and effectiveness study to examine proof of concept with first-time parents using text messages to communicate the intervention. Quantitative information relating to uptake, engagement, retention and effectiveness of the intervention as well as qualitative information (focus groups with parents who took part in the study) will be collected. Overall, the effectiveness of the intervention will be assessed through the APEASE criteria (acceptability, practicability, effectiveness, affordability, safety, equity).
This study can provide initial yet important support for further exploration in the field of bedtime routines in more complicated family structures (parents with more than 1 child, separated families etc.). Also, the implementation of a novel study design (i.e. text messages) could lead to considerable cost savings while maintaining high retention, uptake and engagement from the participants. Should the intervention meet the APEASE criteria, a more comprehensive intervention on bedtime routines for first-time parents will be explored in a more robust (RCT and longitudinal) approach.
Due to the nature of the study, no trial registration is currently in place.
本研究关注初为人父母者所生幼儿睡前最后一小时的活动，即所谓的睡前常规（BTR）。这些活动包括刷牙、读书、洗澡以及睡前避免进食和饮水等。在合适的时间设定固定的就寝时间也非常重要。事实证明，建立良好的睡前常规对于多项健康、幸福、发育和社交成果而言至关重要。目前，尚无针对初为人父母者采用新颖设计（即短信）的循证睡前常规干预措施。现有研究强调了睡前常规的重要性以及寻求支持的父母缺乏适当机制的问题。
拟开展的研究包括2个工作包。工作包1通过定性研究（使用理论领域框架对父母进行关于睡前常规障碍和促进因素的一对一访谈）和关键利益相关者专家组相结合的方式，专注于干预措施的开发。工作包2涉及一项小规模（n = 50）的可行性和有效性研究，以检验向初为人父母者发送短信传达干预措施的概念验证。将收集与干预措施的采用、参与、留存和有效性相关的定量信息以及定性信息（与参与研究的父母进行焦点小组讨论）。总体而言，将通过APEAZE标准（可接受性、实用性、有效性、可负担性、安全性、公平性）评估干预措施的有效性。
本研究可为在更复杂家庭结构（有多个孩子的父母、分居家庭等）的睡前常规领域进行进一步探索提供初步但重要的支持。此外，采用新颖的研究设计（即短信）在保持参与者高留存率、高采用率和高参与度的同时，可大幅节省成本。如果干预措施符合APEAZE标准，将以更稳健的（随机对照试验和纵向）方法探索对初为人父母者进行更全面的睡前常规干预。
由于研究的性质，目前未进行试验注册。
